| CTRI Number |
CTRI/2018/04/013067 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three liquid media instilled in endotracheal tube cuff on haemodynamic changes and postoperative cough,sore throat in neurosurgical patients. |
|
Scientific Title of Study
|
Comparison of the efficacy of intracuff saline, 1% alkalinized lignocaine and 2% alkalinized lignocaine on endotracheal tube induced haemodynamic changes and emergence phenomena in neurosurgical patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mounisha E |
| Designation |
Postgraduate |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9159366179 |
| Fax |
|
| Email |
mounisha.igmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Talwar |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mounisha E |
| Designation |
Postgraduate |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9159366179 |
| Fax |
|
| Email |
mounisha.igmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mounisha E |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 |
Department of Anaesthesia and Intensive Care, Ground floor, main OT building, New Delhi
New Delhi
DELHI |
9159366179
mounisha.igmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neurosurgical cases of age 18-65 years
ASA Grade I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% alkalinized lignocaine group |
Patients in this group will be given general anaesthesia(preoxygenation with 100% oxygen for 3 min, patients will be induced with Inj Fentanyl 1.5 μg/kg IV followed by Inj propofol 1-2 mg/kg and inj vecuronium bromide 0.1 mg/kg IV)After direct laryngoscopy, an appropriate size endotracheal tube will be inserted and the cuff will be inflated with the test drug i.e 1% alkalinized lignocaine at the minimal occlusive volume i.e the volume sufficient to establish a cuff pressure between 25-30cmH2O and (eliminates audible inspiratory leak with IPPV) |
| Intervention |
2% alkalinized lignocaine group |
Patients in this group will be given general anaesthesia(preoxygenation with 100% oxygen for 3 min, patients will be induced with Inj Fentanyl 1.5 μg/kg IV followed by Inj propofol 1-2 mg/kg and inj vecuronium bromide 0.1 mg/kg IV)After direct laryngoscopy, an appropriate size endotracheal tube will be inserted and the cuff will be inflated with the test drug i.e 2% alkalinized lignocaine at the minimal occlusive volume i.e the volume sufficient to establish a cuff pressure between 25-30cmH2O and (eliminates audible inspiratory leak with IPPV)
|
| Comparator Agent |
Saline group |
Patients in this group will be given general anaesthesia(preoxygenation with 100% oxygen for 3 min, patients will be induced with Inj Fentanyl 1.5 μg/kg IV followed by Inj propofol 1-2 mg/kg and inj vecuronium bromide 0.1 mg/kg IV)After direct laryngoscopy, an appropriate size endotracheal tube will be inserted and the cuff will be inflated with the test drug i.e 0.9% saline at the minimal occlusive volume i.e the volume sufficient to establish a cuff pressure between 25-30cmH2O and (eliminates audible inspiratory leak with IPPV) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Neurosurgical cases of age 18-65 years, either
gender with American Society of
Anaesthesiologist’s Grade I and Grade II and
Glasgow coma scale (GCS)-15/15.
2.Duration of surgery >1 hr.
|
|
| ExclusionCriteria |
| Details |
1.Patients with history of sorethroat/URTI/
laryngeal or tracheal pathology;
asthma /COPD; Stridor / Dysphonia;
Oropharyngeal and or neck malformations.
2.Patients with predicted difficult intubation
/>2 attempts of intubation.
3.Patients receiving intravenous lignocaine /
allergic to Local Anaesthetics.
4.Patients who are not immediately extubated
after surgery.
5.Usage of nasogastric / orogastric tube
inrtaoperatively
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of post extubation cough (PEC) and postoperative sore throat (POST) |
1 hour, 8 hours and 24 hours postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Haemodynamic changes
2)Postoperative
dysphonia,dysphagia
3)Postoperative pain,nausea and vomiting
4)Smooth extubation |
At the time of intubation, during the surgery, at the time of extubation and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Shroff,Prerana P,Patil V. Efficacy of cuff inflation media to prevent post intubation-related emergence phenomenon: air, saline and alkalinized lignocaine. Eur J Anaesthesiol 2009;26:458-62.
2.Indu S,Arun MG,Mohamed T. Effect of intracuff media-alkalinised lignocaine, saline, and air on endotracheal tube induced emergence phenomena: a randomized controlled study. J Evid Based Med Healthc 2016;3:3173-77.
3.Wetzel LE,Ancona AL, Cooper AS,Kortman AJ, Loniewski GB, Lebeck LL. The effectiveness of 4% intracuff lidocaine in reducing coughing during emergence from general anesthesia in smokers undergoing procedures lasting less than 1.5 hours. AANA J 2008;76:105-8.
4.Fagan C,Frizelle HP, Laffey J,Hannon V,Carey M. The effects of intracuff lidocaine on endotracheal tube-induced emergence phenomena after general anaesthesia. Anesth Analg 2000;91:201-5.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
1) To compare the efficacy of 2% alkalinized lignocaine with 1% alkalinized lignocaine and saline in reducing postoperative cough and sorethroat. 2) To compare the efficacy of 2% alkalinized lignocaine with 1% alkalinized lignocaine and saline in reducing haemodynamic changes at extubation.
Hypothesis : Intracuff 2% alkalinized lignocaine reduces the incidence of endotracheal tube induced emergence phenomena and haemodynamic changes as compared to 1% alkalinized lignocaine and saline. |